Luca Gallelli
Catanzaro, CZ, 88100, Italy
NCT Number: NCT06814769
This is a prospective longitudinal single-center clinical study on OA patients treated with HA . Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2; ), and 360 days (T3). The first efficacy end-point will be the statistically significant difference (P<0.05) in VAS scale between T2 and T0 and between T3 and T2
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Notify Me18 year–65 year
All sexes
Observational
Catanzaro, CZ, 88100, Italy
This is a prospective longitudinal single-center clinical study on OA patients treated with HA at the Pain Medicine Room of the Clinical Pharmacology and Pharmacovigilance Operative Unit of the "Renato Dulbecco" University Hospital of Catanzaro from January 2023 to December 2024. Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2), and 360 days (T3). At the beginning of the study, all enrolled patients signed the informed consent. After the enrollment (T0) and during the follow ups (T1-T3), clinical and laboratory data will be collected directly by the medical staff involved in the study and Zung SAS, Zung SDS and SF-36 questionnaires will be administered. The dedicated database evaluated and recorded any systemic or local side effects. HA will be administered at the beginning of the study (T0) in agreement with the leaflet.
The first efficacy end-point will be:
the statistically significant difference (P<0.05) in VAS scale between T2 and T0 and between T3 and T2 the statistically significant difference (P<0.05) in functional mobility and walking ability (six minutes walking test) between T2 and T0 and between T3 and T2 the statistically significant difference (P<0.05) in mood disorders (Zung SAS and Zung SDS) between T2 and T0 and between T3 and T2
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intra-articular administration
Time frame: 12 months
Numeric Pain Rating Scale: with a 0-10 points, where 0 is no pain and 10 is extreme pain
Time frame: 12 months
20-items: score 0 - 44: no anxiety; 45 - 59 moderate anxiety; 60 - 80 severe anxiety
Time frame: 12 months
20-items: score 20 to 49: no depression; 49-59 mild; 59-69 moderate; 70 - 80 severe anxiety
University of Catanzaro
Other
Hyaluronic Acid in the Management of Articular Pain
Acronym: HApain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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